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Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy J. Tarbell, M.D., Massachusetts General Hospital Identifier:
First received: March 15, 2005
Last updated: March 14, 2016
Last verified: March 2016

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.

Condition Intervention Phase
Brain and Central Nervous System Tumors Long-term Effects Secondary to Cancer Therapy in Children Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae

Resource links provided by NLM:

Further study details as provided by Nancy J. Tarbell, M.D., Massachusetts General Hospital:

Primary Outcome Measures:
  • Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ]

Secondary Outcome Measures:
  • Neuroendocrine toxicity as measured by CTC v3.0 [ Time Frame: Annually ]
  • Neurocognitive toxicity as measured by CTC v3.0 [ Time Frame: Years 1, 2 and 5 ]

Enrollment: 60
Study Start Date: May 2002
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation therapy
This is a single arm study of radiation therapy with protons to standard doses.
Radiation: radiation therapy
Radiation therapy with proton beam to standard doses

Detailed Description:


  • Determine the 3-year incidence and severity of ototoxicity in young patients with medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and posterior fossa radiotherapy.
  • Determine the incidence of primary hypothyroidism and other endocrine dysfunction (neuroendocrine and end organ) in patients treated with this regimen.
  • Determine the incidence and severity of neurocognitive abnormalities in patients treated with this regimen.
  • Determine the acute side effects of this regimen, including esophagitis, upper and lower gastrointestinal tract disease, and weight loss, in these patients.
  • Determine the 3-year progression-free survival rate of patients treated with this regimen.

OUTLINE: Patients are stratified according to risk (standard vs high).

Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days a week for 6-8 weeks*.

NOTE: *Unless otherwise specified by a co-existing protocol.

Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at baseline and then annually for 5 years; and audiology evaluation at baseline, before each course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.

After completion of study treatment, patients are followed every 3-6 months for 2-5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.


Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed medulloblastoma or pineoblastoma

    • Standard-risk or high-risk disease
  • Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days
  • Requires craniospinal irradiation



  • 3 to 21

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • No more than 1 prior chemotherapy regimen
  • No prior IV or intrathecal methotrexate
  • No prior intrathecal thiotepa
  • Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00105560

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Study Chair: Nancy J. Tarbell, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nancy J. Tarbell, M.D., Attending Radiation Oncologist, Massachusetts General Hospital Identifier: NCT00105560     History of Changes
Other Study ID Numbers: CDR0000415841
P01CA021239 ( U.S. NIH Grant/Contract )
Study First Received: March 15, 2005
Last Updated: March 14, 2016

Keywords provided by Nancy J. Tarbell, M.D., Massachusetts General Hospital:
long-term effects secondary to cancer therapy in children
untreated childhood medulloblastoma
untreated childhood pineoblastoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases processed this record on August 18, 2017